With the exception of applicant's U.S. Pat. No. 4,343,797, authorities in medicine and surgery are agreed that no acceptable substitute for whole human blood now exists. Similar opinion is widespread regarding a substitute for naturally occurring hematocrit.
Compositions such as Albumin, Lactated Ringer's Solution, Dextran, Modified Gelatin, Hydroethyl Starch, Fluorocarbons, and Perfulorocarbons are known in the literature as "Blood Substitutes". (Reference: Chemical Abstracts, 8th Collective Index, 1967-1971). The use of these compositions is restricted to the transport of oxygen and carbon dioxide and the expansion of plasma volume. There is no recorded evidence that these compounds can function as whole blood substitutes or that they are ever used as such. (Reference: Chemical Abstracts; volumes 88, 89, 90, 91, 92, 93 and 94; Index Medicus; annual volumes 1967 to 1981; monthly volumes: January, February, March 1982) Further, the scientific literature cited above records the fact that the use of the aforementioned "blood substitutes" is restricted not only because of their physiological limitations but also because of the adverse reactions and incompatibilities associated with their use.
TABLE I ______________________________________ Present U.S. Pat. No. Invention 4,343,797 Synthetic Whole Synthetic Whole Blood Properties* Human Blood Whole Blood Albumin ______________________________________ 1 Yes Yes Yes 2 Yes Yes Yes 3 Yes Yes Yes 4 Yes Yes Yes 5 Yes Yes Yes 6 Yes, but not equal to Yes Yes that of synthetic whole blood 7 No Yes Yes 8 Yes Yes Yes 9 Increase Can be pre- Can be pre- pared to de- pared to de- crease or in- crease or in- crease % crease % 10 Yes Yes Yes 11 Yes No No 12 No Yes Yes 13 No Yes Yes ______________________________________ Gelatin in- cluding Per- Lactate modi- Al- Hydro- fluoro Ringer's Dex- fied bumin ethyl chem- Properties* Solution tran gelatin 5% Starch icals ______________________________________ 1 No No No No No Yes 2 Yes Yes Yes Yes Yes Yes 3 No No No No No No 4 No No No No No No 5 No No No No No Yes 6 No No No No No No 7 No No No No No No 8 No No No No No No 9 Re- Re- Re- Re- Re- Re- duction duction duction duction duction duction 10 Yes Yes Yes Yes Yes Yes 11 Does Does Does Does Does Yes Not Not Not Not Not apply apply apply apply apply 12 No No No No No Yes 13 Yes Yes Yes Yes Yes Yes ______________________________________ Properties* 1 Oxygen Transport 2 Carbon Dioxide Transfer 3 Oxygen can be held in reserve and released in accordance with physiological tension 4 Hemoglobin can be added or dispersed within the preparation without los of stability 5 Transfers gasses other than O.sub.2 and CO.sub.2 6 Possesses both polar and nonpolar properties 7 Dissolves and transports nonpolar drug entities without loss of dosageform stability 8 Transports enzyme systems without loss of stability 9 Effect on hematocrit percent after transfusion 10 Essential amino acids can be transported in stable form and desired quantity 11 Oxygen uptake ability reduced at low O.sub.2 partial pressures 12 Transports physiologically useful lipid soluble entities as a stable solution 13 Universal donor characteristics
Table I compares (1) the presently disclosed invention with (2) synthetic whole blood (U.S. Pat. No. 4,343,797, (3) whole human blood and (4) the known available substitutes. Note should be taken of the striking functional simularities between the presently disclosed invention, the composition of U.S. Pat. No. 4,343,797 and whole human blood.